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PROMACTA
(eltrombopag) Tablets

WARNING

RISK FOR HEPATOTOXICITY

PROMACTA may cause hepatotoxicity. PROMACTA, in combination with interferon and ribavirin in patients with chronic hepatitis C, may increase the risk of hepatic decompensation [see WARNINGS AND PRECAUTIONS].

  • Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.
  • Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels.
  • Discontinue PROMACTA if ALT levels increase to ≥ 3X the upper limit of normal (ULN) in patients with normal liver function or ≥ 3X baseline in patients with pretreatment elevations in transaminases and are:
    • progressive, or
    • persistent for ≥ 4 weeks, or
    • accompanied by increased direct bilirubin, or
    • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.

DRUG DESCRIPTION

PROMACTA (eltrombopag) Tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production. Each tablet contains eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg, or 100 mg of eltrombopag free acid.

Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{ (2Z)-2-[1 -(3,4-dimethylphenyl)-3-methyl-5-oxo- 1,5-dihydro-4H-pyrazol-4- ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4•2(C2H7NO). The molecular weight is 564.65 for eltrombopag olamine and 442.5 for eltrombopag free acid. Eltrombopag olamine has the following structural formula:

PROMACTA (eltrombopag) Structural Formula Illustration

Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water.

The inactive ingredients of PROMACTA are: Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: hypromellose, polyethylene glycol 400, titanium dioxide, polysorbate 80 (12.5 mg tablet), FD&C Yellow No. 6 aluminum lake (25 mg tablet), FD&C Blue No. 2 aluminum lake (50 mg tablet), Iron Oxide Red and Iron Oxide Black (75 mg tablet), or Iron Oxide Yellow and Iron Oxide Black (100 mg tablet).

What are the possible side effects of eltrombopag (Promacta)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have a serious side effect such as:

  • nausea, pain in your upper stomach, low fever, loss of appetite;
  • dark urine, clay-colored stools;
  • jaundice (yellowing of the skin or eyes);
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or...

Read All Potential Side Effects and See Pictures of Promacta »

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.